Comparison of Hydrophilic Guidewires Used in Endovascular Procedures

ABSTRACT: The development of hydrophilic guidewires has provided the vascular interventionalist with an important tool to more effectively deliver diagnostic and therapeutic equipment. Method. To determine whether significant variation in performance exists between commonly used guidewires, a single-blinded, randomized study was conducted to evaluate three hydrophilic guidewires: the ZipWire (Boston Scientific Corp., Natick, Massachusetts), the HiWire (Cook, Inc., Bloomington, Indiana), and the Glidewire (Terumo Medical Corp., Somerset, New Jersey), which were used by three operators in 100 consecutive vascular disease patients. Dimensions evaluated included trackability, crossing, torque control, feel, support, time through anatomy, radiopacity, lubricity, lubricity retention and tip shape retention. Technical success, procedural success and occurrence of complications were also analyzed. Results. Results demonstrated that for these 10 guidewire characteristics, there was a statistically significant difference among operator ratings of the different hydrophilic wires, with the Glidewire rating statistically significantly higher on all characteristics compared to the other two guidewires. The Glidewire and ZipWire were more likely to have technical and procedural success compared to the HiWire (p Methods The study was approved by the local Emory University Institutional Review Board. All patients who were undergoing peripheral arterial revascularization procedures were eligible for enrollment in this trial. Informed consent was obtained from each consecutive patient who was scheduled to undergo an endovascular procedure during the study period. Randomization and enrollment in the study were initiated when the physician performing the procedure requested a hydrophilic guidewire. The study research coordinator had a three-tier 1:1:1 randomization scheme for the three study guidewires. If the physician decided that another guidewire was needed, the second- or third-tier guidewire was provided in accordance with a predetermined blocked scheme. Protocol. There were three experienced operators who participated in this study and had an average of 10 years’ experience in performing endovascular procedures. When operators requested a hydrophilic 0.035 inch guidewire for clinical reasons, one of the three study guidewires was chosen based on a randomized system and opened for use by study staff. The operator was blinded to which guidewire was opened. All guidewires were flushed with heparinized saline inside the hoop before entry into the body. The physician was given the guidewire and a torque device was placed on the proximal end. If the physician at his/her discretion decided that the given guidewire was not adequately performing at that point, he or she would ask for the next guidewire in the scheme of predetermined randomization. At the end of the procedure, the physician graded the guidewire with respect to specific parameters, which included trackability, crossing, torque control, feel, support, time through anatomy, radiopacity, lubricity, lubricity retention, tip shape retention, technical and procedural success (Table 1). The three operators had extensive discussions about these dimensions to ensure that all were interpreting and rating these characteristics in the same way. For each parameter, three scoring choices were available: 1 = not satisfactory; 2 = somewhat satisfactory; and 3 = satisfactory. Patients. One hundred consecutive patients were enrolled in this study. The average age of the sample was 71 years (range 45–90 years). The demographics and clinical characteristics of these patients are shown in (Table 2) and comprise a high-risk patient population with significant vascular risk. Equipment used. Three 0.035 inch guidewires were compared in this study: the ZipWire (Boston Scientific Corp., Natick, Massachusetts), the HiWire (Cook, Inc., Bloomington, Indiana), and the Glidewire (Terumo Medical Corp., Somerset, New Jersey). Data collection and analysis. Immediately following the procedure, operators completed coding sheets that recorded their scores on each characteristic evaluated for all guidewires used during the procedure. Data was entered into a spreadsheet and transferred to the statistical software package used for data analysis (SPSS version 16.0, SPSS, Inc., Chicago, Illinois). The overall performance rating for each characteristic was evaluated using one-way analysis of variance (F-statistic). For characteristics with significant results, t-tests were used to compare the ratings between individual guidewires. Operator ratings were also analyzed as categorical rankings and were compared using chi-square analysis. The results of these analyses were identical to the ANOVA analyses and are not presented here. Technical success, procedural success and occurrence of complications were also analyzed using chi-square analysis. A p-value Results Rating of characteristics. The operators’ ratings of the guidewire characteristics are shown (Table 3). For each of the 10 characteristics that were judged by the operators, the Glidewire demonstrated a statistically significantly higher rating compared to ZipWire and HiWire guidewires. The proportion of procedures that were diagnostic was 25%. They were distributed as follows: diagnostic Glidewire 27%, ZipWire 31% and HiWire 17%; intervention was performed in 75%, with the Glidewire 73%, the ZipWire 69% and the HiWire 83%; this was not statistically significant (p = 0.359). No significant difference was noted between the ZipWire and the HiWire, although there appeared to be a trend with the ZipWire to receive higher ratings than the HiWire on some of the characteristics. Technical and procedural success between the guidewires was found to be better for the Glidewire and the ZipWire compared with the HiWire (Table 4). The first wire was successful 86% of the time, with a significantly different success rate between the wires (Glidewire 100%, ZipWire 100% and HiWire 90.3%; p Discussion The success of endovascular procedures in peripheral arterial disease is determined by the success of the guidewire to navigate the stenosis or the vascular anatomy. We report here the results of experienced operators evaluating three commonly used hydrophilic guidewires in peripheral vascular disease patients in a single-blinded study. The results confirm the findings reported by Ohki and Huang,12 in which the same guidewires were used in animals. For each of the ten characteristics that were judged by the operators, the Glidewire demonstrated a statistically significantly higher rating compared to the ZipWire and the HiWire. We designed this study to reflect real-world situations in a consecutive case design where physicians determined that there was a clinical need to use a hydrophilic guidewire and graded them using multiple parameters rather than a single characteristic. This design allowed us to capture the strengths and weakness of the individual guidewires. Since physicians were requested to enroll all patients undergoing a peripheral vascular procedure, the guidewires were tested in different anatomical locations in a broad range of patients. This approach exposed both the strengths and deficiencies for each guidewire in dealing with these anatomical variations (Table 5). Due to tortuous anatomy and a contralateral approach in treating lower-extremity arterial disease, physicians tend to use hydrophilic guidewires more commonly to deliver catheters and equipment in these situations. In addition, due to their hydrophilic coating, these guidewires are also preferred when addressing carotid arteries. Failure of the wire was determined by the investigators and judgment was based on inadequate performance of the given wire. In this study, we found that the Glidewire was rated statistically significantly better than the ZipWire and the HiWire in all of the measured characteristics across all of these vascular beds. Due to the hydrophilic nature of these guidewires, they may also result in higher complication rates. Table 4 shows however, that there were no complications due to the study wire in this study sample. Unfortunately, this study was not statistically powered to determine a difference in complications and a much larger study would be needed to evaluate this. Study limitations. The rating scale for this study featured subjective grading of the guidewire characteristics by the operators. We tried to overcome this by using a specific scale to quantify objective measures. Every attempt was made to minimize the possibility of wire identification, but it is possible that the operator was able to do so simply by handling the wire. In addition, the operators in this study had significant experience with endovascular diagnosis and intervention and their experience may not be generalized to other operators and institutions. Conclusion Although imparting hydrophilic coating to guidewires improves performance characteristics, not all hydrophilic guidewires are equal. Other design features have a significant impact on how these guidewires respond during endovascular procedures, which transfer a unique tactile sensation to the operators. The current study demonstrates that the Glidewire was independently rated as having superior characteristics compared to the ZipWire and HiWire in various vascular beds and in a broad range of patients. Every effort was made to limit the influence of the sponsor on the study by using an independent statistician who was also blinded to treatment assignment at the time of data analysis and by employing a blinded, randomized design so that the operator did not exert any product preference. Also, no operator has any financial interest with the study sponsor. Guidewire technology will continue to evolve and studies like these, that are designed to objectively evaluate these guidewires using specific characteristics in a broad range of patients with vascular disease, should provide valuable information for further improvement in design. This will allow physicians to perform these procedures safely and effectively. From the Emory Heart & Vascular Center, Emory University, Atlanta, Georgia, and the California Pacific Medical Center Heart and Vascular Center, San Francisco, California. Dr. Deepak L. Bhatt served as the primary editor for this submission and there was no participation by the Editor-in-Chief in the review or decision process. Disclosures: This study was sponsored by Terumo Medical Corporation, Somerset, New Jersey. Richard Shaw is a paid consultant to Terumo Medical Corp. Manuscript submitted January 20, 2009, provisional acceptance given March 23, 2009, final version accepted April 13, 2009. Address for correspondence: Khusrow Niazi, MD, Emory Heart & Vascular Center, Emory University, Cardiology, MOT Suite 4309, 6th Floor, 550 Peachtree Street, Atlanta, GA 30308. E-mail: kniazi@emory.edu

1. McDermott EA. Coronary angioplasty guidewire technology. Z Kardiol 1987;76(Suppl 6):29–32.

2. Grech ED. Percutaneous coronary intervention. I: History and development. Br Med J 2003;326:1080–1082.

3. Kikuchi Y, Graves VB, Strother CM, et al. A new guidewire with kink-resistant core and low-friction coating. Cardiovasc Intervent Radiol 1989;12:107–109.

4. Corcos T, Favereau X, Guerin Y, et al. Recanalization of chronic coronary occlusions using a new hydrophilic guidewire. Cathet Cardiovasc Diagn 1998;44:83–90.

5. Koizumi J, Mouri M, Watanabe M, Hirawatsu K. Transbrachial selective pulmonary angiography using a new 4 Fr curved pigtail catheter and hydrophilic coated wire. Cardiovasc Intervent Radiol 1998;21:347–349.

6. Poncyliusz W, Falkowski A, Walecka A. Does use of hydrophilic guidewires significantly improve technical success rates of peripheral PTA? Med Sci Monit 2004;10(Suppl 3):55–57.

7. Sharma SK, Israel DH, Kumar K, Ambrose JA. Use of the stiff shaft, straight Terumo Glidewire in crossing stenotic aortic valves. Cathet Cardiovasc Diagn 1993;30:160–161.

8. Freed M, Boatman JE, Siegel N, et al. Glidewire treatment of resistant coronary occlusions. Cathet Cardiovasc Diagn 1993;30:201–204.

9. Gray DF, Sivananthan UM, Verma SP, et al. Balloon angioplasty of totally and subtotally occluded coronary arteries; Results using the hydrophilic Terumo Radifocus Guidewire M (Glidewire). Cathet Cardiovasc Diagn 1993;30:293–299.

10. Aletich VA, Debrin GM, Koenigsberg R, et al. Arteriovenous malformation nidus catheterization with hydrophilic wire and flow-directed catheter. Am J Neuroradiol 1997;18:929–935.

11. Zimarino M, Rasetti G, Venarucci V, Pagliacci M. Terumo Glidewire; The wire of choice for chronic total occlusion. Cathet Cardiovasc Diagn 1995;34:186–188.

12. Ohki T, Huang J. Comparing interventional guidewires in an ex vivo model. Endovascular Today 2006:26–29.

13. Clayman M, Uribe CA, Eichel L, et al. Comparison of interventional guide wires in urology. Which, when and why? J Urol 2004;171:2146–2150.

14. Shah A, Lau C, Stavropoulos W, et al. Comparison of physician-rated performance characteristics of hydrophilic-coated guide wires. J Vasc Inter Radiol 2008;219:400–405.